Colon ResectionPhase 3NCT01613274
The Effect of Gum Chewing on Bowel Motility in Post-operative Colon Resection Patients
A Phase 3 study testing gum chewing and no gum chewing in people with Colon Resection, run by Allina Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon resection surgery decrease the time to first flatus, bowel movement and length of stay in the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Resection
- What is being tested?
- gum chewing and no gum chewing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Unit 2600
- Age 18-100 years of age
- Alert and oriented
- Post-operative open or laparoscopic colon resection
- English speaking.
Who cannot join
- Confused, or with cognitive disabilities that render the patient unable to answer questions about bowel motility.
- Admitted to any other unit except 2600
- Use of an epidural catheter for pain control post-operatively
- Documented history of irritable bowel syndrome
- Colostomy (new or old)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon resection surgery decrease the time to first flatus, bowel movement and length of stay in the hospital.
Read the detailed description
Post-operative colon resection patients experience decreased bowel motility, which may cause pain, nausea/ vomiting, impaired nutritional intake, and abdominal distention. Return of bowel function is a strong determinant in length of hospital stay. There are small studies that have shown that chewing gum post-operatively may enhance bowel motility thus minimizing complications and decreasing length of hospital stay. The purpose of this research study is to determine the effect of gum chewing on bowel motility as measured by time to first flatus, bowel movement and length of stay in patients following a colon resection.
- Conditions
- Colon Resection
- Being tested
- gum chewing, no gum chewing
- Keywords
- colon resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gum chewingOther
gum chewing three times a day for up to 20 minutes
no gum chewingOther
no gum chewing
| Study group | Role | What they receive |
|---|---|---|
| Gum chewing | Experimental | Chewing mint flavored sugarless gum for 10-20 minutes three times a day following colon resection. Receives: Other: gum chewing |
| no gum chewing | Placebo comparator | no gum chewing Receives: Other: no gum chewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first flatus
Measured: Every 4 hours following surgery until discharge, which is an average of 5 days
Secondary outcomes (2)
Time to first bowel movement
Measured: Every 4 hours following surgery until discharge, which is an average of 5 days
Length of stay in days
Measured: Patients will be followed until discharge, which is an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie A Sabo, RN Mn CNS-BC, Principal investigator, United Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613274
- Sponsor's protocol ID
- GCBM
- Status last verified
- Apr 2014
- First submitted
- 3 Jun 2012
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gum Chewing on Bowel Motility in Post-operative Colon Resection Patients
- ClinicalTrials.gov ID
- NCT01613274
- Acronym / sponsor ID
- GCBM
- Conditions
- Colon Resection
- Keywords
- colon resection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon resection surgery decrease the time to first flatus, bowel movement and length of stay in the hospital.
Detailed description
Post-operative colon resection patients experience decreased bowel motility, which may cause pain, nausea/ vomiting, impaired nutritional intake, and abdominal distention. Return of bowel function is a strong determinant in length of hospital stay. There are small studies that have shown that chewing gum post-operatively may enhance bowel motility thus minimizing complications and decreasing length of hospital stay. The purpose of this research study is to determine the effect of gum chewing on bowel motility as measured by time to first flatus, bowel movement and length of stay in patients following a colon resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gum chewing | Experimental | Other: gum chewingChewing mint flavored sugarless gum for 10-20 minutes three times a day following colon resection. |
| no gum chewing | Placebo comparator | Other: no gum chewingno gum chewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to Unit 2600
- Age 18-100 years of age
- Alert and oriented
- Post-operative open or laparoscopic colon resection
- English speaking.
Key exclusion criteria (5 listed)
- Confused, or with cognitive disabilities that render the patient unable to answer questions about bowel motility.
- Admitted to any other unit except 2600
- Use of an epidural catheter for pain control post-operatively
- Documented history of irritable bowel syndrome
- Colostomy (new or old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gum chewinggum chewing three times a day for up to 20 minutes | Other | Gum chewing |
| no gum chewingno gum chewing | Other | no gum chewing |
Primary outcome
Time to first flatus
Time frame: Every 4 hours following surgery until discharge, which is an average of 5 days
2 secondary outcomes
Time to first bowel movement
Time frame: Every 4 hours following surgery until discharge, which is an average of 5 days
Length of stay in days
Time frame: Patients will be followed until discharge, which is an average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Sabo, RN Mn CNS-BC principal investigator
United Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gum chewing and no gum chewing in people with Colon Resection, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first flatus (time frame: Every 4 hours following surgery until discharge, which is an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2014.